Institutional Review Board
Policies and Procedures

Delta State University maintains a federally certified Institutional Review Board (Site designation IORG0001 144). As part of the certification process, the Delta State Institutional Review Board (IRB) has agreed to review protections for human research subjects, whether the project is externally funded or not. Since Delta State does not maintain animal colonies for research, we have not sought and do not review research proposals for their protection.

Sources

As is true for most universities, the Delta State IRB policies are extensions of the Belmont Report (1979) and the relevant Code of Federal Regulations published in the Federal Register (31 pp; 45CFR46; June 23, 2005). The Belmont Report is a brief, superlatively written document outlining ethical principles for guidance. It is the most basic document and should be read by anyone involved in human research. Detailed regulations governing human research are found in 45CFR46. Subpart A of 45CFR46 outlines general regulations while Subparts B and C address the needs of “vulnerable” populations such as children, pregnant women, inmates in correctional or mental institutions, and low-income citizens. Both of these documents may be downloaded from the Office of Human Research Protections (OHRP). The Delta State IRB Chair and Site Auditors offer workshops every year for continuing education of faculty and others involved in human research.

How is “research” defined?

Many types of informal investigations do not require review by the IRB since they do not meet the operational criteria defined in 45CFR46 as ‘research’. Those criteria are that 1) there is a formal research design, and 2) there is an intention to publish or present results at a professional meeting. In some cases, an informal investigation will lead to a serendipitous finding that will invite further scrutiny. If that happens, investigators should immediately request that the IRB review the proposed project for protection of human subjects.

The Process

Faculty, student and other persons conducting research in collaboration with Delta State must fill out the one page “Request for IRB Clearance" Form A. No request will be considered without this completed form with required signatures and attachments. Required attachments include letters of Informed Consent and Assent, and copies of all surveys and questionnaires. For more information, see Criteria for Informed Consent and Assent, Appendix A. If the Primary Researcher is not a full-time Delta State employee, a Research Sponsor will also be required to sign the form. Eligible Research Sponsors must be full time Delta State employees or an adjunct who supervises theses and dissertations. The form and attachments may be mailed, e-mailed, faxed, or hand delivered to the IRB Chair (contact information is on the forms).

Issues that most frequently jeopardize an IRB Clearance include 1) problems with Informed Consent Statements to be signed by adults and parents of minors; 2) problems with Informed Assent Statements to be signed by minors who are research subjects; and 3) subtle coercion of subjects. For example, giving extra points to subjects who participate but not having equal points available to non-research subjects for an alternative activity is unacceptably coercive. Or, if a teacher or faculty member suggests that students should really try to “help out the researcher” provides mildly coercive pressure to participate.

The IRB Chair will review the completed application within two weeks, and notify the applicant of its status. There are four possibilities. First, if the application is judged to have ‘minimal risk’ it will be classified as EXEMPT from further IRB Review. For details, see Criteria for Exempt Status, Appendix B. The IRB Chair may require minor changes before granting the exempt status. Second, if risks are considered greater than minimal, research may still be eligible for EXPEDITED REVIEW by three IRB members For details, see Criteria for Expedited Review, Appendix C. Research which does not qualify for EXEMPT Status or Expedited Review must have a FULL IRB REVIEW See Request for Full IRB Review, Form C. Fourth, in rare cases, the IRB Chair may judge that the proposed research is UNACCEPTABLE in its present form. No research on human subjects may begin until cleared by the IRB! In all cases, the researcher has the right to appeal the IRB Chair’s decision to the Full IRB.

Full IRB Reviews

The full IRB Review will be conducted by a quorum (50%) of IRB Members with a designated recording secretary. In no case may a Full IRB hearing have less than five IRB members present. IRB members will be appointed on the basis of ensuring diversity of academic disciplines, sex, and ethnicity. Additionally, at least one IRB member must be from a discipline that does not usually conduct research on human beings. Also, at least one IRB member must not be an employee of Delta State University. After discussion of the proposed research using a cost/benefit valuation, votes of the IRB will be recorded in the following format: Number voting ‘Yes’; number voting ‘No’; and number abstaining.

After IRB Clearance has been granted

The signed Request for IRB Clearance form gives two assurances from the researchers to the IRB. First, any event that jeopardizes human research subjects will be immediately reported to the IRB Chair and/or the Provost’s office in case the IRB Chair is unavailable. Second, there must be assurance of a Continuing Review if the research lasts longer than one year. If any phase of externally funded research, including the write-up, extends beyond one year, researchers will submit a "Request for Continuing IRB Review" Form B. The rules are more relaxed for internally sponsored research such as Master's Thesis or a Faculty Research Committee Grant. For these internal affairs, Continuing Review is not required after data collection is complete. However, the researcher make advance agreement that all records will be confidential and will be destroyed when no longer neded.

Special IRB Regulations for externally funded research

The Office of Human Research Protections (OHRP of the U.S. Department of Human Services) has reviewed the Delta State IRB Procedures and made the following recommendations for externally funded research projects. On January 17, 2006, the Delta State IRB voted to incorporate all recommendations into our existing IRB Policies and Procedures.

Training Materials for Protection of Human Subjects

In order to ensure that researchers are familiar with the principles and practice of ethical research, the Delta State IRB conducts training workshops at least annually. In addition, the materials listed below can assist researchers as they prepare the IRB Request for Clearance and conduct the research.

On-line Tutorial

A free on-line IRB tutorial is available from the New York University School of Medicine. From their web page, follow the hyperlink for the "IRB Tutorial On-Line" listed under "IRB Resources". To proceed, the researcher will have to enter the name "Guest". After the tutorial has been completed (23 objective items which can be repeatedly answered until you achieve a "Correct" response on each item), the tutorial will send you a brief email certifying your participation and request your actual name and university. When these have been entered, your name will appear in their on-line registry.

The Office of Human Research Protections (OHRP) provides an additional wealth of resources including more on-line training, decision charts for complex IRB cases, a training pamphlet (It's your decision), and other guidances. Other recommended resources are available in Appendix G.

Some Historical Incidents Related to Human Subjects Protections

• Hippocrates (400 BCE) and Oath: “Do no harm ...“
• Individual responsibility of researcher - two millennia
• Walter Reed (1900) Consent forms in Spanish and English: malaria research
• Nuremburg Code (1946) Twenty-six medical researchers from holocaust tried for unethical conduct toward “vulnerable” population. Rules and principles developed.
• Wichita, Kansas (1950’s) Secret audio taping of jury deliberations for legal research. University of Chicago challenged in Congress by James Eastland (of Ruleville, MS).
• NIH Clinical Research Center at Bethesda (1960) sets up internal review committee and many other research hospitals voluntarily follow suit.
• Thalidomide, an experimental drug in Europe was allowed for use in the United States with waiver of clinical trials by FDA(1962). Those receiving drug were not warned that it was still ‘experimental’.
• Sloan-Kettering conducts research using “live” cancer cells on humans (1963). Subjects were told that research was testing their resistance to cancer, but not that they would receive live cancer cells. One MD tried to stop it and took Sloan-Kettering to court where defendants were convicted of assault & battery. Malpractice was also shown.
• James Shannon (1964) at NIH reviews protections for all human subjects in NIH ffinded research. Agency begins taking a leading role in protecting human subjects.
• Stanley Milgram (1965) conducted famous research on ‘obedience’, using deception as part of the design. Despite debriefing, a strong outcry from other professionals.
• Henry K. Beecher (1966) reviewed biomedical research literature and showed that human subjects protections were violated in over 500 papers. His analysis was published in the New England Journal of Medicine and in two books (see References).
• PHS research on untreated syphilis (1972) was initiated in the Alabama in the 1930’s. The longitudinal project continued for years, and even after the use of penicillin, 300+ African American subjects were left untreated (and uninformed). Senator Edward Kennedy challenged this research in Congress, which incorrectly became known as the ‘Tuskegee Institute Study’ (Tuskegee had nothing to do with it).
• The National Research Act (1974) was passed by Congress. IRB’s were established and a National Commission for Protection of Human Subjects was established.
• The Belmont Report (1978) was published, based on the Presidentially commissioned work of MD Psychologists, Lawyers, and Biomedical and Behavioral Ethicists. This beautifully reasoned and written document proposed to go beyond “rules and regulations” to propose principles to use in judgments about protecting human subjects.
  • Respect for Persons
  • Beneficence
  • Justice
• Vulnerable subject samples (1980-present). More recently, guidelines and regulations have been developed to guide researchers on protecting rights of “vulnerable” subjects including economically disadvantaged, minority, prisoners, mentally incompetent, pregnant mothers, fetuses, and even fetal tissues. While these issues are important, the volume of effort by Congress and federal agencies clearly illustrate political implications, rather than the moral or ethical considerations which are more important.
• Recent Controversies and Issues
  • Undue Inducement
  • Duke University
  • Third Party Informed Consent (Oral History and the Human Genome Project)
  • Johns Hopkins “An artist’s reply to just criticisms ...”. Dimitri Shostakovitch.

The Nuremburg Code

Following the atrocities in medical research during the Holocaust of WWII, this code was developed to provide specific rules intended to prevent future abuse of research subjects. The Nuremburg Code differs from the later Belmont Report in that the later developed general principles and provided far more depth of understanding for research ethics.

1. The voluntary consent of the human subject is absolutely essential.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seemed to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

For more information, contact:

Dr. Dan R. McFall, IRB Chair
PO Box 3217, Delta State University, Cleveland, MS 38733
Phone: 662-846-4395 Fax: 662-846-4869
Email: dmcfall@deltastate.edu

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